Quality of life and symptom assessment in randomized clinical trials of bladder cancer: A systematic review

On behalf of Patient-Reported Outcome Measurements Over Time In Oncology-PROMOTION Registry

Research output: Contribution to journalArticlepeer-review

12 Citations (Scopus)


Objectives: Patient-reported outcomes (PRO) help patients, caretakers, clinicians, and policy makers make informed decisions regarding treatment effectiveness. Our objective was to assess the quality of PRO reporting and methodological strengths and weaknesses in randomized controlled trials (RCT) in bladder cancer. Methods: A systematic literature search of bladder cancer RCT published between January 2004 and March 2014 was performed. Relevant studies were evaluated using a predetermined extraction form that included trial demographics, clinical and PRO characteristics, and standards of PRO reporting based on recommendations of the International Society for Quality of Life Research. Results: In total, 9 RCTs enrolling 1,237 patients were evaluated. All studies were in patients with nonmetastatic disease. In 5 RCTs, a PRO was the primary end point. Most RCTs did not report the mode of administration of the PRO instrument or the methods of collecting data. No RCT addressed the statistical approaches for missing data. Conclusions: We found that few RCTs in bladder cancer report PRO as an outcome. Efforts to expand PRO reporting to more RCTs and improve the quality of PRO reporting according to recognized standards are necessary for facilitating clinical decision making.

Original languageEnglish
Pages (from-to)331.e17-331.e23
Number of pages7
JournalUrologic Oncology: Seminars and Original Investigations
Issue number7
Early online date5 May 2015
Publication statusPublished - Jul 2015

Bibliographical note

We are grateful to the EORTC Quality of Life Group for having supported the development of the PROMOTION Registry. We also acknowledge the essential contribution of Alessandro Perreca and Salvatore Soldati, from the GIMEMA Health Outcomes Research Unit, for data management. The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.


  • Bladder cancer
  • Clinical decision making
  • Clinical trials
  • Patient-reported outcomes
  • Quality of life


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